Compliance Management Featured Articles

  1. Raw Material Considerations For Cell Therapies 6/16/2025

    For cell therapy developers, selecting appropriate raw materials is a significant challenge. Examine key considerations for mitigating risk and aligning with current regulatory expectations.

  2. Scope 3 Emissions: A Shared Challenge, A Collective Responsibility 6/13/2025

    Despite growing sustainability efforts, our industry lags in climate goals, especially Scope 3 emissions. Discover why bold action and deep collaboration across the value chain are essential for real progress.

  3. How A Rigorous Approach Delivers Unparalleled Results 6/12/2025

    In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.

  4. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

  5. The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns 6/3/2025

    In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

  6. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  7. Revolutionizing Pharma Validation With AI 5/28/2025

    Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

  8. The Impact Of The FDA's New CSA Draft Guideline 2/24/2025

    Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

  9. Increasing Drug Manufacturing Efficiency With Intelligent Master Batch Record Design 2/24/2025

    Discover how to enhance your pharmaceutical production efficiency with an intelligent MBR design that offers tailored software, handling systems, and inspection machines.

  10. Does My Cleanroom Facility Need A Residue Removal Step? 3/28/2024

    Explore the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.